Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands.
Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands.
J Bone Joint Surg Am. 2024 Sep 4;106(17):1583-1593. doi: 10.2106/JBJS.23.00793. Epub 2024 May 31.
Orthopaedic Data Evaluation Panel (ODEP) ratings of total hip (TH) and total knee (TK) implants are informative for assessing implant performance. However, the validity of ODEP ratings across multiple registries is unknown. Therefore, we aimed to assess, across multiple registries, whether TH and TK implants with a higher ODEP rating (i.e., an A* rating) have lower cumulative revision risks (CRRs) than those with a lower ODEP rating (i.e., an A rating) and the extent to which A* and A-rated implants would be A*-rated on the basis of the pooled registries' CRR.
Implant-specific CRRs at 3, 5, and 10 years that were reported by registries were matched to ODEP ratings on the basis of the implant name. A meta-analysis with random-effects models was utilized for pooling the CRRs. ODEP benchmark criteria were utilized to classify these pooled CRRs.
A total of 313 TH cups (54%), 356 TH stems (58%), 218 TH cup-stem combinations (34%), and 68 TK implants (13%) with unique brand names reported by registries were matched to an ODEP rating. Given the low percentage that matched, TK implants were not further analyzed. ODEP-matched TH implants had lower CRRs than TH implants without an ODEP rating at all follow-up time points, although the difference for TH stems was not significant at 5 years. No overall differences in CRRs were found between A* and A-rated TH implants, with the exception of TH cup-stem combinations, which demonstrated a significantly lower CRR for AA-rated cup-stem combinations at the 3-year time point. Thirty-nine percent of A*-rated cups and 42% of A*-rated stems would receive an A* rating on the basis of the pooled registries' CRR at 3 years; however, 24% of A-rated cups and 31% of A-rated stems would also receive an A* rating, with similar findings demonstrated at longer follow-up.
At all follow-up time points, ODEP-matched TH implants had lower CRRs than TH implants without an ODEP rating. Given that the performance of TH implants varied across countries, registries should first validate ODEP ratings with use of country-specific revision data to better guide implant selection in their country. Data source transparency and the use of revision data from multiple registries would strengthen the ODEP benchmarks.
Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.
矫形数据评估小组(ODEP)对全髋关节(TH)和全膝关节(TK)植入物的评分对于评估植入物的性能很有帮助。然而,多个登记处之间 ODEP 评分的有效性尚不清楚。因此,我们旨在评估多个登记处中,评分较高(即 A*)的 TH 和 TK 植入物的累积翻修风险(CRR)是否低于评分较低(即 A)的植入物,以及基于汇总登记处的 CRR,A和 A 级植入物中有多少会被评为 A。
根据植入物名称,将登记处报告的特定植入物的 3 年、5 年和 10 年的累积翻修风险与 ODEP 评分相匹配。利用随机效应模型进行荟萃分析,对 CRR 进行汇总。利用 ODEP 基准标准对这些汇总的 CRR 进行分类。
共有 313 个 TH 杯(54%)、356 个 TH 柄(58%)、218 个 TH 杯柄组合(34%)和 68 个 TK 植入物(13%),这些植入物在登记处有独特的品牌名称,并与 ODEP 评分相匹配。由于匹配的比例较低,TK 植入物没有进一步分析。在所有随访时间点,与没有 ODEP 评分的 TH 植入物相比,具有 ODEP 匹配的 TH 植入物的 CRR 较低,尽管 TH 柄在 5 年时没有显著差异。除了 TH 杯柄组合外,在 A和 A 级 TH 植入物之间没有发现 CRR 总体差异,在 3 年时,A和 A评级的杯柄组合的 CRR 明显较低。基于汇总登记处的 3 年 CRR,39%的 A级杯和 42%的 A级柄将获得 A评级;然而,24%的 A 级杯和 31%的 A 级柄也将获得 A*评级,在更长的随访时间内也有类似的发现。
在所有随访时间点,具有 ODEP 匹配的 TH 植入物的 CRR 均低于没有 ODEP 评分的 TH 植入物。鉴于 TH 植入物在不同国家的性能存在差异,登记处应首先使用特定国家的翻修数据验证 ODEP 评分,以更好地指导其国家的植入物选择。数据来源的透明度和使用多个登记处的翻修数据将增强 ODEP 基准。
治疗性 3 级。请参阅作者说明以获取完整的证据水平描述。